Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 911-436-4 | CAS number: 61932-63-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 03 MAY 1976 to 06 MAY 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report which meets basic scientific principles.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Fed. Reg. Vol. 38, No. 187, p. 27019, 1973
- Deviations:
- not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 61932-63-6
- Test material form:
- solid: nanoform, no surface treatment
- Details on test material:
- Name of test material (as cited in study report): Permanentrot F6RK CM 86745
Analytical purity: 45.1 % (w/w) (comp. 1) Pigment Red 170, 53.6 % (w/w) (comp. 2) Pigment Red 266
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: single
- Diet: standard diet (ERKA 8300, Futtermittelwerke Robert Koch , Hamm. Germany), ad libitum
- Water: ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 100 mg - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: with physiological saline
- Time after start of exposure: 24 h
SCORING SYSTEM: basically in accordance with OECD TG 405.
Scores were read 1, 7, 24, 48 and 72 h after test substance application.
TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein at 48 and 72 h reading
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effects
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not relevant since no effects
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 3
- Reversibility:
- other: reversibility not relevant since no effects
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effect
- Irritant / corrosive response data:
- - no iridial or corneal effects were visible at any time point.
- in the 1 h reading 1/6 animal showed an conjunctivae redness score of 1. This effect was completely reversible within 7 h.
- no chemosis was observed at any time point.
- discharge scores for animal #1,2,3,4,5,6 after 1 h: (0,1,1,1,0,1), after 7 h: (0,1,0,1,0,0), after 24 h: (0,0,0,1,0,0). After 48 and 72 h scores for all animals were 0.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was not irritating to eyes in all animals under test conditions which are basically in accordance with todays standard methods regarding dosing, exposure duration, scoring system and reading time points. Therefore, it is concluded that the submission substance is not irritating to eyes.
- Executive summary:
Test material was subject to a test of eye irritancy according to FDA guidelines (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973). 100 mg of substance were applied to one eye of six animals each. The eyes were washed 24 h after application and eye responses were noted for 72 h. Only very slight effects were visible. After 1 h discharge was observed in 4/6 animals and conjunctivae redness in 1/6 animals. Conjunctivae redness was completely reversible within 7 h. Discharge was completely reversible within 48 h. No corneal or iridial effects were visible at any time point as well as no chemosis. Therefore, it is concluded that the submission substance is not irritating to eyes.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
